EP0437773A2 - Moyen de diagnose pour détection de cholestérol - Google Patents

Moyen de diagnose pour détection de cholestérol Download PDF

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Publication number
EP0437773A2
EP0437773A2 EP90124752A EP90124752A EP0437773A2 EP 0437773 A2 EP0437773 A2 EP 0437773A2 EP 90124752 A EP90124752 A EP 90124752A EP 90124752 A EP90124752 A EP 90124752A EP 0437773 A2 EP0437773 A2 EP 0437773A2
Authority
EP
European Patent Office
Prior art keywords
cholesterol
scleroprotein
film
detection
reagent film
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
EP90124752A
Other languages
German (de)
English (en)
Other versions
EP0437773A3 (en
EP0437773B1 (fr
Inventor
Anselm Dr. Rer. Nat. Rothe
Heino Dr. Rer. Nat. Eikmeier
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Roche Diagnostics GmbH
Original Assignee
Roche Diagnostics GmbH
Boehringer Mannheim GmbH
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Roche Diagnostics GmbH, Boehringer Mannheim GmbH filed Critical Roche Diagnostics GmbH
Publication of EP0437773A2 publication Critical patent/EP0437773A2/fr
Publication of EP0437773A3 publication Critical patent/EP0437773A3/de
Application granted granted Critical
Publication of EP0437773B1 publication Critical patent/EP0437773B1/fr
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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Classifications

    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/34—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving hydrolase
    • C12Q1/44—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving hydrolase involving esterase
    • C12Q1/46—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving hydrolase involving esterase involving cholinesterase
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/60—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving cholesterol
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S435/00—Chemistry: molecular biology and microbiology
    • Y10S435/805—Test papers

Definitions

  • the invention relates to a diagnostic agent for the enzymatic detection of cholesterol, a method for producing a reagent film for the detection of cholesterol, the use of scleroproteins or scleroprotein hydrolyzates to improve diagnostic agents and a method for the determination of cholesterol.
  • test strips have proven to be particularly suitable.
  • the prerequisite for the success of such patient systems is the perfect functioning of the test strips and easy handling. Objective results that are independent of the person performing the determination can practically only be obtained by means of a measuring device.
  • diagnostic agents which contain the reagents required for the detection in the form of a film on a test strip.
  • the production of such a reagent film is described, for example, in EP-B-0016387.
  • the object of the present invention was therefore to provide diagnostic means for a largely temperature-independent determination of cholesterol.
  • the invention relates to a diagnostic agent for the enzymatic detection of cholesterol, which contains a scleroprotein or scleroprotein hydrolyzate in addition to the necessary enzymes.
  • Diagnostic agents for the enzymatic detection of cholesterol are known, for example from EP-B-0016387. These agents preferably contain an enzymatic redox system for the oxidation of cholesterol. The extent of cholesterol oxidation can be determined via a color formation reaction or electrochemically.
  • the preferred main components of a diagnostic agent containing a film composition containing cholesterol oxidase and cholesterol esterase can be found in EP-B-0016387.
  • the diagnostic agent according to the invention contains a scleroprotein or scleroprotein hydrolyzate.
  • Scleroprotein hydrolyzates made of collagen or elastin with a molecular weight between approximately 1,000 and 15,000 are particularly preferred.
  • Crotein C with a molecular weight of approximately 10,000 is particularly preferred.
  • a particularly preferred embodiment of the diagnostic agent according to the invention contains a film former, for example polyvinyl propionate, mineral carriers such as diatomaceous earth and titanium dioxide, a suitable pH buffer, cholesterol oxidase, cholesterol esterase, peroxidase and a redox-active chromogen, for example tetramethylbenzidine.
  • a film former for example polyvinyl propionate, mineral carriers such as diatomaceous earth and titanium dioxide, a suitable pH buffer, cholesterol oxidase, cholesterol esterase, peroxidase and a redox-active chromogen, for example tetramethylbenzidine.
  • a reagent film with this composition is preferably used as a reagent film in DE-A-3130749 or EP-A-0045476.
  • the reagent film is preferably attached to a plastic film.
  • the scleroprotein or scleroprotein hydrolyzate is added to the raw film mass, as is known, for example, from EP-B-0 016 387, in a concentration of 1 to 5% by weight, preferably 2 to 3% by weight, based on the total mass.
  • the mass is then spread out, preferably on a plastic film, and dried.
  • scleroproteins or scleroprotein hydrolyzates in enzyme-containing diagnostic agents for the detection of cholesterol increases the enzyme stability.
  • the use of scleroproteins or scleroprotein hydrolyzates ensures that the detection of cholesterol in enzyme-containing diagnostic agents is largely temperature-independent. This allows at least a restriction to an inexpensive rough temperature control in the measuring device.
  • the present invention also relates to a method for determining cholesterol using a reagent film, the reagent film containing the abovementioned scleroproteins or scleroprotein hydrolyzates.
  • a liquid sample such as blood, urine, serum or saliva, preferably serum
  • a reagent film which contains the reagents required for the determination and the additives according to the invention.
  • the cholesterol is released and oxidized by the reagents and the reducing agent formed is detected by a color reaction.
  • the reaction with peroxidase and tetramethylbenzidine is particularly preferred here.
  • the cholesterol contained in the sample can be determined optically, but preferably by means of a measuring device, by means of the resulting color, the intensity of which is proportional to the amount of cholesterol.
  • the detection can also be done by reflectance photometry, as described in EP-A-0 075 766.
  • FIG. 1 shows a test strip for determining cholesterol, which contains a reagent film 1 according to the invention on a transparent carrier film 2.
  • a sample is placed on the test strip on the right side so that it flows through an erythrocyte separation fleece 3 and is collected in the transport fleece 4.
  • the determination reaction is started by pressing the carrier film with the reagent film onto the transport fleece. The discoloration of the reagent film is observed through the carrier film.
  • the film is spread with a 0.2 mm wet film thickness onto a transparent, 0.2 mm thick polycarbonate film (Lonza, Whyl) and dried at 60 ° C.
  • the reagent film is installed in a test strip according to FIG. 1.
  • the measurements are carried out on a reflection photometer for cholesterol test strips, for example reflotron (Boehringer Mannheim GmbH), as described in EP-B-0 075 766.
  • the result allows a restriction to an inexpensive rough tempering in the measuring device.

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  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Wood Science & Technology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Zoology (AREA)
  • Engineering & Computer Science (AREA)
  • Immunology (AREA)
  • Biochemistry (AREA)
  • Microbiology (AREA)
  • Molecular Biology (AREA)
  • Analytical Chemistry (AREA)
  • Biotechnology (AREA)
  • Physics & Mathematics (AREA)
  • Biophysics (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Genetics & Genomics (AREA)
  • Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Surgical Instruments (AREA)
  • Measuring Pulse, Heart Rate, Blood Pressure Or Blood Flow (AREA)
EP90124752A 1990-01-17 1990-12-19 Moyen de diagnose pour détection de cholestérol Expired - Lifetime EP0437773B1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE4001155 1990-01-17
DE4001155A DE4001155A1 (de) 1990-01-17 1990-01-17 Diagnostisches mittel zum nachweis von cholesterin

Publications (3)

Publication Number Publication Date
EP0437773A2 true EP0437773A2 (fr) 1991-07-24
EP0437773A3 EP0437773A3 (en) 1993-03-24
EP0437773B1 EP0437773B1 (fr) 1995-07-26

Family

ID=6398220

Family Applications (1)

Application Number Title Priority Date Filing Date
EP90124752A Expired - Lifetime EP0437773B1 (fr) 1990-01-17 1990-12-19 Moyen de diagnose pour détection de cholestérol

Country Status (5)

Country Link
US (1) US5268269A (fr)
EP (1) EP0437773B1 (fr)
JP (1) JPH05103699A (fr)
AT (1) ATE125574T1 (fr)
DE (2) DE4001155A1 (fr)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6821410B2 (en) * 2001-03-07 2004-11-23 Matsushita Electric Industrial Co., Ltd. Biosensor and method of substrate quantification

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE2937012A1 (de) * 1978-09-18 1980-04-03 Henkel Kgaa Mittel zur stabilisierung von enzymen und deren verwendung
EP0016387A1 (fr) * 1979-03-15 1980-10-01 Roche Diagnostics GmbH Moyen diagnostique pour la détermination de composés constitutifs de liquides

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE3029579C2 (de) * 1980-08-05 1985-12-12 Boehringer Mannheim Gmbh, 6800 Mannheim Verfahren und Mittel zur Abtrennung von Plasma oder Serum aus Vollblut

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE2937012A1 (de) * 1978-09-18 1980-04-03 Henkel Kgaa Mittel zur stabilisierung von enzymen und deren verwendung
EP0016387A1 (fr) * 1979-03-15 1980-10-01 Roche Diagnostics GmbH Moyen diagnostique pour la détermination de composés constitutifs de liquides

Also Published As

Publication number Publication date
EP0437773A3 (en) 1993-03-24
DE4001155A1 (de) 1991-07-18
JPH05103699A (ja) 1993-04-27
EP0437773B1 (fr) 1995-07-26
US5268269A (en) 1993-12-07
DE59009438D1 (de) 1995-08-31
ATE125574T1 (de) 1995-08-15

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